Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers

A Randomized Controlled Multicenter Clinical Trial Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06693570

Acronym

THOR

Enrollment

150

Registered

2024-11-18

Start date

2024-11-25

Completion date

2026-11-30

Last updated

2025-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonhealing Venous Leg Ulcer, Venous Leg, Venous Leg Ulcers, Venous Leg Ulcer (VLU)

Keywords

Fish Skin Graft, Intact Fish Skin Graft

Brief summary

The purpose of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of hard-to-heal venous leg ulcers (VLU) between Intact Fish Skin Graft plus standard of care (IFSG/SOC) versus standard of care alone (SOC) over 12 weeks.

Detailed description

This is a randomized controlled multicenter clinical trial evaluating intact fish skin grand and standard of care vs. standard of care alone in nonhealing venous leg ulcers. The product classifies as a medical device and consists of a full thickness fish-skin that has been processed using Kerecis™ Limited's proprietary EnviroIntact™ method.

Interventions

OTHERIntact Fish Skin Graft (IFSG) + Standard of Care

Participants will receive weekly applications of MariGen and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHERStandard of Care

Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Multicenter Prospective Randomized Comparative Effectiveness Clinical Trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Subjects must be at least 18 years of age or older. 2. Subjects must have a nonhealing venous leg ulcer present for a minimum of 4 weeks and cannot have received more than 52 weeks of high-level compression prior to the initial screening visit. 3. No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks. 4. At randomization, subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 25 cm2 measured post-debridement. 5. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable: 1. ABI between 0.7 and ≤ 1.3; 2. TBI ≥ 0.6; 3. TCOM ≥ 40 mmHg; 4. PVR: biphasic. 6. If the potential subject has two or more ulcers, and they are separated by at least 2 cm post-debridement, the largest ulcer satisfying the inclusion and

Exclusion criteria

will be designated as the target ulcer. If the potential subject has two or more ulcers and they are separated by less than 2cm, the entire wound area is designated as the target ulcer. 7. Subjects must have a Functional Ambulatory Category Score (FACS) of 3 or greater. 8. Subjects must consent to using the prescribed compression method for the duration of the study. 9. Subjects must agree to attend the weekly study visits required by the protocol. 10. Subjects must be willing and able to participate in the informed consent process.

Design outcomes

Primary

Measure	Time frame	Description
The percentage of target ulcers achieving complete wound closure	[Time Frame: 1-12 Weeks]	The percentage of target ulcers achieving complete wound closure in 12 weeks

Secondary

Measure	Time frame	Description
Percent area change	[Time Frame: 1-12 weeks]	Percentage wound area change from TV-1 to TV-13 measured weekly with digital photographic planimetry and physical examination.
Adverse Events	[Time Frame: 1-12 weeks]	The number of adverse events.
Change in pain in target ulcer	[Time Frame: 1-12 weeks]	Change in pain in the target ulcer assessed using the Visual Analog Scale VAS scale from TV-1 to TV-13
Time to closure	[Time Frame: 1-12 weeks]	The time to closure of the target ulcers over 12 weeks.
Quality of life using the Wound quality of Life questionare wQOL	[Time Frame: 1-12 weeks]	Change in quality of life using the wQOL checklist \[TV-1, TV-4, TV-8, and TV-12/Final Visit\].
Determine improvement in Quality of Life - Forgotten Wound Score FWS	[Time Frame: 1-12 weeks]	Quality of Life assessed using the Forgotten Wound Score. The scale has a score of 0 to 100- 100 being the worst outcome meaning the wound bothers the subject most of the time. \[TV-1, TV-4, TV-8, and TV-12/Final Visit\].
Visits and product applications needed to close the ulcer	[Time Frame: 1-12 weeks]	The number of visits and product applications needed to close the ulcer

Countries

United States

Contacts

Primary ContactBarkley Booker

bbooker@serenagroups.com888-960-1343

Backup ContactThomas Serena, MD

serena@serenagroups.com814-688-4000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026